Parent-based Intervention for Language Delayed 2 to 3 Year Olds

NCT03083236 | Unknown

• 1 other identifier: Solent NHS Trust
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the impact of parent based intervention on the language of 2 to 3 year old children from socially disadvantaged populations with a clinical diagnosis of primary language delay.

Conditions

Speech and Language Therapy

Outcome Measures

Primary Outcomes (1)

• The Pre-School Language Scales 5 UK (PLS 5 UK)

  The planned primary outcome measure for the proposed RCT is a quantitative measure of child language using a standardised assessment measure, The Pre-School Language Scales 5 UK (PLS 5 UK) (Zimmerman et al, 2014). This will provide a sound measure of reliability and validity.

  2 years

Interventions

Standard PBI OTHER

Standard Parent Based Intervention (PBI)

Enhanced OTHER

Enhanced Parent Based Intervention (EPBI)

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child is 24-36 months old
• The child has little or no expressive language (a vocabulary of 40 or less single words)
• The child has no known aetiology; the language delay is not secondary to sensory, structural, neurological or cognitive impairments
• The family have been assessed as having low socioeconomic status The study will use the Index of Multiple Deprivation (IMD) as a basis to determining a measure of deprivation. The IMD combines information from seven domains (income, employment, education, health, crime, housing and living environment) to produce an overall measure and it ranks how deprived areas are relative to others. This will be used to determine which areas and Children's Centres will be involved in the proposed RCT. However, as this is a geographical ranking, the RCT will include further refinement of eligibility of social disadvantage via assessment of individual measures of income deprivation, employment deprivation and education attainment. This information on employment and parent education levels will be collected via the case history taken at the initial assessment, as this is standard practice in a profile of risk for child language delay. The additional information on income will be taken at the first research assessment, as this does not form part of standard practice

You may not qualify if:

• The child's expressive language consists of a vocabulary of more than 40 single words
• The child's language delay is secondary to sensory, structural, neurological or cognitive impairments
• English is not the first language for the family.
• Where English is not the first language, children would be excluded. Adjustments to the protocol and delivery of intervention would be required where English is an additional language (EAL) and there is a need to test the intervention first on an English-speaking population. If effective, a longer term programme plan would be to amend the programme and evaluate the effectiveness with EAL children.

Sponsors & Collaborators

• Solent NHS Trust: lead

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 17, 2017
• Study Start: October 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 10, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share